Recommended
More Related Content
What's hot
What's hot (20)
Similar to Medical device reporting 27 sep2016
Similar to Medical device reporting 27 sep2016 (20)
More from Ann-Marie Roche
More from Ann-Marie Roche (20)
Recently uploaded
Recently uploaded (20)
Medical device reporting 27 sep2016
- 1. 1 Medical Device Reporting Presented by: Dr. Joyce de Langen, Doctor of Pharmacy Sr Solution Manager Pharmacovigilance Elsevier Life Sciences Date: 27th of September 2016
- 2. 2 Outline • What is a medical device? • Classification of Medical Devices • Regulations • Medical device adverse event reporting • How does Elsevier support your Medical Device Development and monitoring?
- 3. 3 What is a medical device? • A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which: − Is intended for use in the diagnosis, treatment/cure, mitigation or prevention of disease in humans or animals − Does not act through chemical actions or which does not need to be metabolized before acting >> that means which is no drug − Is recognized in official National Formulary or USP http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm
- 4. 4 Types of Medical Devices Capital Equipment Instruments Disposables & Accessories Implantable devices Monitoring systems Reagents Computerized Medical systems
- 5. 5 Levels of FDA Medical Device Classification Class I Low Risk Bandages, dental floss, examination gloves Class II Medium Risk Electric wheelchair, Infusion pumps, Class III (life-sustaining) High Risk Pacemakers, heart valves, brain stimulators, coronary stent
- 6. 6 US Approval Process for medical devices http://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/validation-requirements-medical- device-design-manufacture-processing/
- 7. 7 Medical Device Market is Growing https://www.zionmarketresearch.com/news/global-medical-device-coatings-market
- 8. 8 Increase in Medical Device Revenue leads to increase in adverse event reports for medical devices
- 9. 9 Origin of Medical Device Adverse Event Reports https://www.tga.gov.au/sites/default/files/medical-devices-post-market-vigilance-statistics-2014.pdf
- 10. 10 US: FDA Medical device Reporting 21 CFR 803 A MDR Reportable Event is defined as: • An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury of a patient OR • An event that manufacturers/importers become aware of that reasonably suggests that one of their marketed devices – May have caused or contributed to a death or serious injury – Has malfunctioned and that may potentially cause or contribute to death or serious injury when the event would recur
- 11. 11 Another few definitions… • Becomes aware: – An employee of the manufacturer/importer or device user facility who is required to report medical device events has received/acquired information that reasonably suggests a reportable event has occurred • Caused or contributed also includes events occurring as a result of: – Failure, malfunction, improper or inadequate design, manufacture, labelling or user error • Serious injury or illness includes any event that: – Is life-threatening – Results in permanent disability of patient or impairment of body functions – Requires medical /surgical intervention to prevent permanent disability/ impairment • Malfunction refers to failure of a medical device to meet its performance specifications
- 12. 12 Medical Device Problems or Adverse Events • An event whereby a medical device has, or may have, caused or contributed to a death or serious injury. • Includes events resulting from: – Problems with Instructions/labeling/packaging – Failure to work as intended/malfunction – Improper or inadequate device design – Manufacturing problems – Interactions with other devices – Defects – Software problems – Use errors – Combinations of the above
- 13. 13 Mandatory MDR reporting requirements Reporter What to report To whom Timelines for reporting Manufacturer Reports of deaths, serious injuries and malfunctions FDA Within 30 days of becoming aware Manufacturer -Specific type of events upon request by FDA -Event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health FDA Within 5-days of becoming aware (5-day report) Importer Reports of deaths and serious injuries FDA and manufacturer Within 30 days of becoming aware Importer Reports of malfunctions Manufacturer Within 30 days of becoming aware
- 14. 14 Summary of mandatory reporting requirements- Continued Reporter What to report To whom Timelines for reporting Device User facility# Device-related Death FDA and manufacturer Within 10 work days of becoming aware Device User facility Device related Serious Injury Manufacturer (FDA only when manufacturer is unknown) Within 10 work- days of becoming aware (5-day report) Device User facility Annual summary of death & serious injury reports FDA January 1st of the preceding year http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm#2 # hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities.
- 15. 15 Manufacturer MDR Requirements • Supplemental reports are required when -New information comes available after the submission of the initial report -Report within 30 days after receiving the additional/corrected information • Submit required information on FDA MedWatch Form 3500A or in electronic equivalent as approved. • Implement a complaint procedure to ensure that complaints are evaluated to determine whether the complaint represents in fact an event which should be report under 21CFR803 • Develop, maintaine, implement MDR Standard operating procedures
- 16. 16 Medical Device Non-compliance issues during FDA Inspections
- 17. 17 FDA- Sent warning letters to 12 Medical Device Companies http://www.massdevice.com/fda-sends-warning-letters-12-medical-device-companies/
- 18. 18 Poll: Multiple adverse events on different days in same patient with same device How you report adverse events involving the same patient and same device but occurring on different days? A) Submit one report describing all occurrences of the reportable event in the patient. B) Submit one report describing all the reportable events in the patient for each day the event occurred. C) Submit one report describing the reportable event for the patient for each occurrence
- 19. 19 Poll: Multiple adverse events on different days in same patient with same device How you report adverse events involving the same patient and same device but occurring on different days? A) Submit one report describing all occurrences of the reportable event in the patient. B) Submit one report describing all the reportable events in the patient for each day the event occurred. C) Submit one report describing the reportable event for the patient for each occurrence
- 20. 20 EU Directives for Medical Devices • Active Implantable Medical Device Directive AIMD 90/385/EEC • Medical Device Directive MDD 93/42/EEC • In Vitro Diagnostic Device Directive IVDD 98/79/EC
- 21. 21 Stakeholders Medical Device Marketing • Manufacturing Medical device Manufacturers Subcontractors • Local entities implementing MDD at national level in each EU member state Competent authorities • Organizations that are authorized to perform audits manufacturers QMS and test/assess the compliance of medical devices Notified bodies • Any Manufacturing company that has no affiliate in EU Authorized representatives • Companies distributing Medical Devices in EUDistributors
- 22. 22 Post-marketing Surveillance (PMS) of Medical Device Reporting in EU • Implementation of PMS is required for all Medical devices sold in EU • PMS should include a systematic review and analysis of postproduction information including: – Clinical follow-ups – Quality complaints – Customer feedback, – Vigilance – New scientific Information – Literature • Manufacturers need to develop proactive plans for PMS • Systematic record management of PMS data
- 23. 23 Vigilance Reporting for Medical Devices in EU • Notification of Competent Authorities about Incidents occurring with medical devices • Qualified Representative to submit Medical Device Incident Reports Incident is defined in the EU Medical Device Regulatory Documents as • Any Malfunction or deterioration in the characteristics and/or performance of a device, including also insufficient labeling, insufficient instructions for use , that may lead to the death of a patient or to a serious deterioration of his/her health • Any technical or medical reason in relation to the characteristics or performance of a device leading to systematic recall of devices of the same type
- 24. 24 Software as Medical Device • Software becomes a medical device when the manufacturer or supplier intends for the software to be used in: – Diagnosis – Prevention – Monitoring – Treatment or alleviation of disease
- 25. 25 Examples of events with Software Medical Devices • Software problems – Vital signs monitor did not transmit information to central station – Software glitches with new software installation – Virus infects device operating software – Day-light savings software considerations
- 26. 26 Software verification and validation is an essential tool for ensuring medical device software is safe. http://medicaldeviceacademy.com/category/software-verification-and-validation/
- 27. 27 Literature as source of MDR reportable events …..Reports of deaths or serious injuries. You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury. … https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803&showFR=1
- 28. 28 How does Elsevier R&D Life Sciences Portfolio support MDR Reporting? Embase supports Medical Device Development and PMS Quosa PV support triage and review of literature to identify reportable events Journals like Smart Health
- 29. 29 Introducing QUOSA PV : Elsevier’s GxP-compliant PV- solution for literature management Conference Documents Online literature database Journal RSS Feeds PSURs ICSRs OTHER SAFETY & COMPLIANCE REPORTS A combination of software and services that allows customers to reduce risk, remain compliant and ensure that workgroups have the latest scientific literature Supervisors Track deadlines And bottlenecks • Automatic alerts import • Article deduplication • E2B case data export • Document listing exports in Vancouver format for PSURs Administrators View all aspects of the review process
- 30. 30 Embase supporting Medical Device Development and Post Marketing Surveillance
- 31. 31
- 32. 32
- 33. 33
- 34. 34 Thank you! For more information about Embase and Quosa PV visit also https://www.elsevier.com/rd- solutions Dr. Joyce de Langen Sr Solution Manager Pharmacovigilance j.delangen@elsevier.com